Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers

Phase 1

Completed

• Conditions: DLBCL; Advanced Cancers; Lymphoma
• Interventions: Drug: IONIS-STAT3Rx

• Registration Number: NCT01563302
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-13
• Study Start: 2012-02-27
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-26
• Primary Completion: 2016-03-23
• Study Completion: 2016-03-23
• Status Verified: 2018-06
• Disposition First Submitted: 2018-06-20
• Disposition First Submitted QC: 2018-06-20
• Last Update Submitted: 2018-06-20
• Disposition First Posted: 2018-06-25
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Aged 18 years or older
• Tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists
• Expansion cohort only: Advanced lymphoma confirmed by histopathology
• Measurable or evaluable disease according to RECIST for solid tumors or according to IWRC for NHL tumors
• ECOG Performance Status less than or equal to 2
• Life expectancy greater than 12 weeks in the opinion of the Investigator

Exclusion Criteria

• Any active or uncontrolled infection
• NYHA Grade II or greater congestive heart failure
• History of myocardial infarction within 6 months prior to screening
• Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	IONIS-STAT3Rx	IONIS-STAT3Rx

Primary Outcome Measures

Name	Time	Method
Safety of IONIS-STAT3Rx in patients with Advanced Cancers	Approximately 28 days after last dose of IONIS -STAT3Rx
Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers.	Approximately 28 Days	Highest dose level at which no more than 1 out of 6 patients develops a DLT

Secondary Outcome Measures

Name	Time	Method
Clinical activity of IONIS-STAT3Rx	Approximately 28 Days after last dose of IONIS-STAT3Rx	Measured by RECIST in the study population who have measurable disease or relevant disease specific response criteria
STAT3 and other biomarkers	Approximately 28 days after last dose of IONIS-STAT3Rx	The effect of treatment with IONIS-STAT3Rx on phospho-STAT3 and other biomarkers
Pharmacokinetics-Cmax	Approximately 28 days after last dose of IONIS-STAT3Rx	Maximum observed drug concentration (Cmax)
Pharmacokinetics - Tmax	Approximately 28 days after last dose of IONIS-STAT3Rx	Time taken to reach Cmax

Trial Locations

Locations (9)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Moores UC San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Mary Crowley Cancer Research Centers; 🇺🇸 Dallas, Texas, United States

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

Blood and Marrow Transplant Group of Georgia at Northside Hospital; 🇺🇸 Atlanta, Georgia, United States